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FDA Updates for the Week of Sept. 25, 2023

The FDA has approved several new therapies this week, including a new two-component Pompe therapy, an extended-release drug for major depression without sexual side effects, and an eye drop for drug-induced dilation. Additionally, the agency has set review dates for several products, including odronextamab for blood cancers, sotatercept for pulmonary arterial hypertension, and Dupixent in young children with eosinophilic esophagitis.

CMS Has Changed the Game for Medicare Advantage Reimbursement. Here’s How Plans Can Respond Effectively.

Jeremy Berk, senior vice president of Risk Adjustment Solutions for PopHealthCare and Emcara Health, shares how plans must conduct a detailed analysis of how changes to risk adjustment models impact your plan in order to set an effective go-forward strategy.

Chances of Developing Gout Are Higher for Patients With IBD

Study links inflammatory bowel disease diagnosis to increased gout risk, with Crohns disease and ulcerative colitis linked to 68% and 38% increases in likelihood of developing gout, respectively, relative to counterparts without IBD.

Children With Asthma Experience Improved Lung Function With Dupixent Initiation

Two posters presented at the European Respiratory Society International Congress found use of Dupixent improved lung function by 12 weeks with sustained responses.

‘What makes a cancer diagnosis so challenging is the complexity of the cancer journey,” says Jennifer Goldsack, CEO of the Digital Medicine Society

Goldsack discussed applying AI and full-stack virtual care-first solutions in oncology and the Digital Medicine Society’s role in CancerX, one of the Biden administration’s Cancer Moonshot initiatives in a recent interview with Managed Healthcare Executive.

‘Done well, there are very few boundaries around the digitization of healthcare,’ says Jennifer Goldsack, CEO of the Digital Medicine Society

Goldsack also pointed to Podimetrics and its SmartMat product, which detects the warning signs of diabetic foot ulcers, as a digital health success story: “That is the sort of thing we want to see.”

‘While we are tech enthusiasts, we are certainly not tech determinists,’ says Jennifer Goldsack, CEO of the Digital Medicine Society

Goldsack also explained the Digital Medicine Society’s role as a convener and developer of evidentiary frameworks in a recent interview with Managed Healthcare Executive.

Patient-Oriented Scoring System for Atopic Dermatitis Reliable, Effective
Sickle Cell Disease Finally Getting its Due

Two possibly curative gene therapies for the disease, which disproportionately affects Black people, are under consideration by the FDA.

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